Can a hydrogel injection ease knee arthritis pain?

NCT ID NCT05057559

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are observing people with knee osteoarthritis who receive an injection of Arthrosamid, a hydrogel, into the affected knee. The study follows about 200 adults over the long term to track side effects and changes in pain, stiffness, and physical function. Because it is an open-label observational study, everyone knows they are getting the injection and there is no comparison group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Arthrosamid, a hydrogel injection given into the knee joint
What this could lead to
If the injection helps, it could offer people with knee osteoarthritis a long-lasting option that eases pain and stiffness without surgery.
What could go wrong
This is an observational study, not a randomized controlled trial, so it cannot prove the injection causes any improvement. Knee injections can also cause temporary pain, swelling, or, rarely, joint infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

201 people

The number who actually took part.

Started

Apr 2021

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients will be recruited from participating rheumatology or orthopedic centers.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged ≥ 18 years * Clinical diagnosis of knee OA Exclusion Criteria: * If an active skin disease or infection is present at or near the injection site * If the joint is infected or severely inflamed * If a degradable intra-articular injectable such as hyaluronic acid is present, it must be expected to be absorbed according to manufacturer's information for the specific product, before injection with Arthrosamid® * If the patient has previously received treatment with a different non-absorbable injectable/implant * If the patient has received a knee alloplasty or has any foreign material in the knee * If the patient has undergone knee arthroscopy within the last 6 months * If the patient has haemophilia or is in uncontrolled anticoagulant treatment

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AP-HM hopitaux

    Marseille, France

  • AmBeNet Hausarztpraxis

    Leipzig, Germany

  • Clinique Saint Louis

    Poissy, France

  • London North West University Healthcare

    London, United Kingdom

  • Ospedale San Pietro Fatebenefratelli

    Rome, Italy

  • Reumatolog i Odense

    Odense, Denmark

  • Royal Cornwall Hospital

    Truro, United Kingdom

  • The Parker Institute

    Copenhagen, Denmark

  • University Medical Center of Johannes Gutenberg-University Mainz (UMC-Mainz)

    Mainz, 55131, Germany

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